MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a depth gauge was broken.It is unknown if there were patient and procedure involvement.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 319.006; synthes lot: ft00149; supplier lot: ft00149; release to warehouse date: november 09, 2016; manufacturing site: synthes monument; supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation flows: broken and visual (appearance not as expected) visual inspection: visual inspection of the returned depth gauge performed at customer quality (cq) confirmed the condition of needle breakage, which agrees with the reported complaint condition; as such the complaint is confirmed.The proximal end of the needle has broken off at its interface with the slider body.The broken off needle portion was returned.Additionally, the distal tip of the broken off needle is significantly bent.It was also noticed that the protection sleeve component was not returned.Device history record (dhr) review: the returned device was manufactured in november 2016.No ncrs were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Document/specification review: the following design drawings, reflecting the manufactured and current revisions, were reviewed: depth gauge assembly needle component protection sleeve component the depth gauge for 2.0mm and 2.4mm screws (319.006) is a reusable instrument available in at least 14 systems used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Dimensional inspection: the diameter of the proximal end of the needle near breakage measured ø1.23mm at cq (calipers ca215p) which is within specification of ø1.25mm +0/-0.05mm per needle component design drawing.The width of the distal tip of the needle near bends measured ø0.79mm at cq (calipers ca215p) which is within specification of ø0.8mm ± 0.05mm per needle component design drawing.Material review: the design specifies the needle component to be manufactured from 316l extra hard stainless steel.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Conclusion: a definitive root cause for the needle bending and breaking could not be determined based on the provided information.It should be noted that the missing protection sleeve component has a primary function of protecting the needle component from damage.This complaint is confirmed, however, no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8195234
• MDR Text Key: 131382568
• Report Number: 2939274-2018-55559
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819707238
• UDI-Public: (01)07611819707238
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: FT00149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1